Continuing New Jersey’s efforts to hold accountable those responsible for fueling the State’s opioid epidemic, Attorney General Gurbir S. Grewal today announced that his office has filed complaints against four physicians for inappropriately writing “off-label” prescriptions for high dosages of the powerful opioid and cancer pain medication “Subsys” without regard for the associated risks of addiction, overdose, and death.
In a fifth case, the State successfully revoked the license of a doctor for the same conduct. All five doctors wrote prescriptions for non-cancer patients after receiving substantial payments from the drug’s manufacturer, Insys Therapeutics, Inc., which tried to disguise the kickbacks to doctors by funneling them through a sham speaker program funded by the company.
The four doctors whose licenses the State seeks to suspend or revoke for their role in the scheme and for inappropriately prescribing Subsys are Dr. Mukaram Gazi of Hamilton, Dr. Serge Menkin of Holmdel, Dr. Kieran Slevin of Hainesport, and Dr. Felix Roque of West New York.
Subsys, a highly addictive, fast-acting fentanyl spray fifty times more potent than heroin, is approved by the Food and Drug Administration (FDA) only for the narrow purpose of treating breakthrough cancer pain in opioid-tolerant patients.
From 2012 through 2016, Doctors Gazi, Menkin, Slevin and Roque received more than $50,000 each from Insys disguised in the form of speaking and consulting fees, and, as a result, prescribed Subsys indiscriminately in circumstances for which the drug was not approved.
One patient of Dr. Roque overdosed, while in other cases, the doctors’ patients were placed at heightened risk of addiction, overdose, and death.
In a separate action, the State successfully revoked the license of Dr. Alexandru Burducea, who was recently sentenced to nearly five years in prison by a New York federal court for his role in the Subsys kickback scheme.
“We will hold accountable all those whose misconduct has helped fuel the opioid epidemic in New Jersey,” Attorney General Grewal said. “Today, we’re taking action against multiple doctors who sold their medical licenses and prescription pads to Insys and put their personal financial interests above their patients’ health and well-being. These actions should serve notice to those who unlawfully push opioids from their exam rooms that they are not above the law and are no different than those that push heroin on street corners.”
“As our actions today demonstrate, we are committed to holding everyone accountable who is involved in illegal and unethical kickback schemes that have contributed to the overdose epidemic in this state,” Paul R. Rodríguez, Acting Director of the Division of Consumer Affairs, said. “We will not allow patients in this state to be used as pawns in moneymaking schemes that pose extreme dangers to patient safety, violate basic principles of medical ethics, and erode trust in the medical profession.”
“These five doctors acknowledged that they had read the risks associated with Subsys and understood that it was approved only for narrow uses as a cancer pain medication,” Sharon Joyce, Director of NJ CARES, said. “Nevertheless, they chose to ignore the unequivocal risks to their patients in favor of the easy money Insys was offering. Their unsavory collaboration with Insys endangered their patients and undermined efforts to end the opioid crisis and prevent more lives from being lost.”
Actions to Suspend or Revoke Licenses of Four Doctors
The Attorney General is asking the State Board of Medical Examiners to suspend or revoke the licenses of the four physicians the State alleges indiscriminately prescribed Subsys in exchange for kickbacks from Insys summarized as follows:
From 2013 through 2015, Dr. Mukaram Gazi, a urologist, allegedly accepted Insys-funded dinners described as “lectures,” trips for “training,” and payments totaling more than $132,000, which Insys thinly disguised as “speaker’s fees.”
In addition to allegations of indiscriminate prescribing for multiple patients, the State’s complaint notes that Gazi’s signature appeared on forms used to obtain insurance coverage for Subsys prescriptions, which incorrectly identified Gazi’s specialty as oncology and provided false explanations for why Subsys was being prescribed.
From 2012 through 2016, Dr. Serge Menkin, a pain management specialist, allegedly accepted $111,000 from Insys, which also paid for travel and expenses for both him and his guests.
According to the State, Insys repeatedly paid Menkin thousands of dollars to deliver remarks before audiences that included zero to one prescriber; in at least one instance, Insys paid Menkin in full for an event that was canceled.
From 2013 through 2016, Dr. Kieran Slevin, an anesthesiologist, allegedly accepted more than $83,000 in cash payments that Insys thinly disguised as “speaker’s fees,” as well as lavish dinners posing as “lectures,” and all-expense-paid trips for “training.”
According to the State’s complaint, Slevin’s speaker events were held at high-end restaurants chosen by him and were sparsely attended, often by repeat attendees, including those who did not have any prescribing authority.
From 2013 through 2015, Dr. Felix Roque, a pain management specialist, allegedly accepted more than $53,000 in “speaker’s fee” payments from Insys, in addition to meals and travel. As alleged in the complaint, an Insys sales representative advised her superiors that Roque would not prescribe Subsys “until he attended a conference,” and that he had asked “to be put up” at the Fairmont Princess, a luxury hotel in Scottsdale, Arizona.
Shortly thereafter, Roque attended a conference in Arizona, funded by Insys and subsequently began prescribing Subsys. As also alleged in the complaint, one of Roque’s patients overdosed on a Subsys prescription he wrote.
Subsys is one of six transmucosal immediate-release fentanyl ("TIRF") medications that instantly deliver the powerful painkiller fentanyl through the oral membranes.
Because TIRF medicines carry a high risk for misuse, abuse, addiction, overdose, and serious complications due to medication error, the FDA has subjected these medications to significant restrictions.
Each of the physicians in today’s complaints allegedly prescribed Subsys for patients without cancer, despite the fact that the FDA had approved Subsys only for breakthrough cancer pain in patients who had grown tolerant to other opioids.
In many cases, they prescribed the drug to patients who were already on steady pain management regimes, in amounts that exceeded the authorized starting dosage.
In some cases, after starting their patients on Subsys, the State alleges that the doctors steadily, without justification or regard for patient safety, increased the dosage strength resulting in more money for Insys because higher doses cost more.
The doctors’ medical records often provided little or no medical justification - and sometimes no explanation at all - as to why patients were switched to Subsys or why their dosages were increased or started at an amount exceeding the authorized starting dosage.
The State is seeking to suspend or revoke the doctors’ licenses on grounds of fraud, professional misconduct, gross negligence that endangered the life and safety of their patients, and/or indiscriminate prescribing of a controlled dangerous substance.
The Division of Consumer Affairs’ Enforcement Bureau conducted these investigations. The cases are being handled by DAsG from the Professional Boards Prosecution Section in the Division of Law’s Affirmative Civil Enforcement Practice Group and from NJ CARES. Assistant Section Chief David M. Puteska is representing the State in the Roque matter; DAG Kathy Stroh Mendoza is representing the State in the Slevin matter; DAG Kelly Elizabeth Levy is representing the State in the Gazi matter, and DAG Michael Antenucci is representing the State in the Menkin matter.
Actions Against Other Indiscriminate Prescribers of Insys Products
The complaints against Drs. Roque, Gazi, Menkin, and Slevin are only the latest of the State’s actions to hold accountable prescribers who indiscriminately prescribed Subsys after receiving suspect payments from Insys.
Attorney General Grewal also announced today that the Board of Medical Examiners has revoked the New Jersey medical license of Manhattan anesthesiologist Alexandru Burducea, who pleaded guilty in Manhattan federal court last year to accepting $68,000 in bribes and kickbacks from Insys in exchange for prescribing Subsys.
In January, he was sentenced to nearly five years in federal prison. During his sentencing, it was revealed that Burducea had also cheated on the examination required for him to be permitted to prescribe Subsys, lied to FBI agents about his involvement in the Insys speaker program, and posted false patient reviews online for two doctors who fired him after he was arrested for his involvement in the scheme.
Based on his criminal conviction and personal conduct, the Board revoked Burducea’s license, finding that he engaged in repeated acts of gross negligence and professional misconduct, indiscriminate prescribing, and other conduct that violated the laws and regulations of the medical profession.
Before the actions announced today, New Jersey barred from practice the following doctors who indiscriminately prescribed Subsys to non-cancer patients:
Kenneth P. Sun, a Phillipsburg pain management practitioner, had his license revoked in August 2018, after he accepted $117,000 from Insys and prescribed Subsys to patients who did not meet the federal criteria for receiving it.
Vivienne Matalon, a Cherry Hill family physician, had her license revoked in May 2018, for indiscriminately prescribing Subsys to three patients who did not meet the federal criteria for receiving it, including one who died from an overdose.
Manoj Patharkar, who owned pain management centers in Middlesex and Passaic counties, had his license revoked in November 2016, for indiscriminately prescribing Subsys, among other misconduct.
Louis Spagnoletti, a Marlton pain management specialist, was temporarily barred from treating patients in March 2018, amid allegations he indiscriminately prescribed opioids including Subsys to seven patients. Spagnoletti died before disciplinary action was concluded.
DAG Nisha S. Lakhani from the Professional Boards Prosecution Section in the Division of Law’s Affirmative Civil Enforcement Practice Group is representing the State in the Burducea matter.
Holding Insys Management Accountable
Finally, a separate lawsuit brought by the State against Insys’s founder, John N. Kapoor is pending in Superior Court in Middlesex County and accuses Kapoor of directing and approving the payment of bribes to New Jersey doctors who participated in the speaker program so that they would inappropriately prescribe Subsys, among other fraudulent conduct.
Today, the state filed its motion for summary judgment in that case and the filing explains that “[t]he harm that Kapoor’s scheme has inflicted on New Jersey and its residents continue to this day. Thousands of New Jerseyans die annually from drug overdoses – most of them opioid overdoses. And tens of thousands more would be dead but for emergency medical interventions and costly treatment for opioid addiction.”
The State’s motion for partial summary judgment would resolve only certain claims against Kapoor, without the need for a trial. The amount of money that Kapoor must pay the State would be determined later.
Insys also is a defendant in the State’s lawsuit against Kapoor, but litigation against the company has been on hold since the company declared bankruptcy and filed a plan of liquidation.
The Kapoor case is being handled by Section Chief and Deputy Attorney General (DAG) Lara Fogel, and DAsG Eric Boden, Brian DeVito and Dana Vasers, all from the Government & Healthcare Fraud Section in the Division of Law’s Affirmative Civil Enforcement Practice Group.